Chiltern International is a well established global contract research organization with offices throughout Europe, North America and India. We were established in 1982 and have served pharmaceutical, biotechnology, and device companies in over 38 countries worldwide. Due to our continued growth, Chiltern is seeking a highly motivated individual to join us as a Senior Clinical Research Associate.

SUMMARY OF POSITION:

The SCRA is a high-profile role within the Department, using their experience as a ‘knowledge resource’ to help other CRAs develop their skills. The SCRA will provide expert advice, guidance and general supervision to Clinical Monitoring team activities for designated projects, and to monitor specified sites to ensure quality and integrity of data, compliance with Chiltern International or Client’s SOPs, ICH GCP, regulatory requirements, ensuring study completion on time and within budget. They may be called upon to interact independently with Clients not directly involved in their projects, and to assist in some relevant departmental tasks.

The SCRA is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The degree of responsibility given to a SCRA shall reflect his/her experience and the level of contribution, which he/she can make to that project.

PREFERRED SKILLS:

· A BSc or BA degree in a biomedical or related life science, or nursing qualification

· Previous CRA experience within clinical research, approximately 5+ years

· Must have at least 5 years Monitoring and 4 years HIV

· Demonstrated ability to conduct the majority of clinical monitoring activities effectively, efficiently and with the minimum of supervision

· Good clinical knowledge with an understanding of medical terminology

· An understanding of the basics of physiology and pharmacology

· Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications

· Good oral and written communication, organisational skills and personal presentation. The ability to communicate effectively in English.

· Experience working in a team environment under time and resource pressures

· Understanding of the principles of ICH GCP and regulatory requirements

· Experience of the clinical research process and terminology

· Preferable experience using a clinical trial management system (CPMS)

KEY ATTRIBUTES:

· Experience as a CRA on multicentre trials, showing appreciation of the role required of LCRA

· Positive outlook on the role of the Department and on Departmental or Company policy

· Good understanding of the work performed by other Chiltern International functions and how they interact

· Understanding of the principles of Project Management and appreciation of the wider issues affecting the efficiency and running of the department

· Aptitude for working independently with minimal supervision

· Proven experience in all clinical aspects of a trial with a strong knowledge of SOPs and accepted practices

· Proven experience of good interpersonal and communication skills when dealing with Sponsors, supporting colleagues and making presentations

· Able to organise and oversee multiple ongoing tasks, and understand the differing priorities

Chiltern’s unique corporate culture encourages a healthy balance of personal life and work. We offer an excellent salary and benefit package to include medical, dental, vision, company matching 401K, excellent vacation & holiday, paid life insurance, AD&D, long and short term disability and many other employee incentives. If you have the experience required and feel you are the dynamic person we are looking for, please forward your resume in a Word document via email to: uscareers@chiltern.com